Intravascular catheters commonly become colonized with bacteria and/or fungi during the indwelling period. The longer a catheter is allowed to remain in place the greater the probability of colonization and secondary infection of the patient. This is particularly common with multilumen catheters entering either the subclavian or internal jugular veins. Since the probability of colonization is a function of the indwelling time, these catheters are commonly exchanged with a new sterile catheter through the same site over a guidewire. Present techniques for guidewire exchange, however, are cumbersome and are difficult to perform while maintaining sterility.
The technique for guidewire exchange involves the preparation of the old catheter site at the point of entrance of the catheter into the patient. Using the fingers and commonly utilizing a stiff guide covering the distal portion of a J-tipped catheter, the guidewire is inserted from a guidewire container through the distal port of a multilumen catheter until the guidewire extends well into the catheter. The catheter is then withdrawn over the guidewire. Subsequent to this, a new sterile catheter is inserted over the guidewire in the old catheter's place. The guidewire is then removed and the catheter is attached to a fluid system.
Unfortunately, it is common for the old catheter to contaminate the physician's gloves during the procedure and, therefore, contaminate the new catheter by transfer of these bacteria during the insertion process (conventional multilumen catheters are generally 20-30 cm in length). A variety of techniques utilizing multiple drapes and multiple sets of sterile gloves are well known in the art. These techniques remain cumbersome and unreliable. It is particularly difficult to maintain a sterile field for the guidewire which remains within the insertion site at the time the old catheter is removed. This guidewire is flexible and a large portion of this guidewire must remain out of the patient to avoid excessive penetration into the patient which could result in cardiac or vascular injury. It is very difficult for the physician to maintain the sterility of this flexible guidewire within a sterile field which is commonly contaminated by the old catheter which has been removed and may have contacted the surrounding environment in juxtaposition with the guidewire. In fact, a recent study has shown that guidewire exchange may not be associated with a reduction in infection-related complications. This failure to reduce infection may be due to the fact that many of the sterile catheters which are exchanged over guidewires are contaminated during the exchange process.
For these reasons, there has long been a critical need to provide an inexpensive over-the guidewire catheter exchange system which eliminates the potential for contamination of the new catheter during catheter exchange.